Innovation and Drugs Price and Reimbursement: A Comparison between Italy and the other Major EU Countries

Innovazione e regolazione del prezzo e del rimborso dei farmaci: un confronto tra Italia e gli altri principali Paesi europei

Abstract

This paper aims at investigating (i) differences and commonalities of drugs Price and Reimbursement (P&R) criteria between Italy and the other major EU countries and (ii) comparative advantages, pitfalls and possible reforms of the Italian model. In the main EU countries P&R is converging towards a contractual model where therapeutic added value and economic impact are playing a crucial role. However there are still important differences across countries in the way added value is measured, the comparators are chosen and the economic impact is integrated with clinical evidence. Compared to the other systems the main advantages of the Italian model are (i) the explicit adoption of a multiple criteria approach, which has allowed a higher flexibility in P&R negotiation, and (ii) that managed market entry contracts have been often used to manage uncertainty at market launch. However, the assessment process is not transparent, innovativeness and premium price have never been explicitly integrated and price negotiation is strongly influenced by a budget silos approach. The former two pitfalls can be faced in the short-term, whereas giving up spending caps on drugs would require a longer-term political consensus.